Tuesday, April 9, 2013

Topic 27: Disruptive Change in CD and the Opportunity it Presents to
MSLs

Disruptive change is a frequent topic on this blog because it represents both a threat and opportunity for MA Leaders. For example, I have discussed the Caroniarulingatlength because it could fundamentally alter the relationship between MA and Commercial.

Clinical Development is facing a disruptive change of its own that not only will alter the way it works but offers an interesting opportunity for some MSL groups.

As most of my readers know, one of the largest expenses in executing a clinical trial is monitoring costs. The need to send a human being to each site every 4 to 8 weeks during a trial to manually review the paper source records and compare those results to the data entered in the electronic data capture (EDC) system accounts for roughly 30% of a major study’s budget.

However, this is about to change. With the rise of tablet computers and ubiquitous internet, a range of technology platforms are now available to allow for the elimination of paper-based source records. For example, the company Clinical Ink, provides a Windows tablet that completely eliminates the need for paper source records by recording not just that data required for the study sponsor (which is what is in the EDC) but also the data needed by the physician administering the study to manage their records. Once the physicians can eliminate the need to keep separate paper records, the last stumbling block to all electronic source records will have been overcome.

All electronic source records is a highly disruptive change to clinical development. All electronic source records means that source data verification no longer needs to occur on-site. The majority of the monitoring visits could be eliminated and the role of the Clinical Research Associate (CRA) versus role of the Clinical Data Manager (CDM) will change significantly.

Today CRA’s do more than just monitoring visits. They also conduct site initiation visits, and other high-visibility meetings with the site to ensure that it is on track. However, when you eliminate the need for monitoring visits, it opens an opportunity to ask if the CRA is really the best representative to provide other support to the site.

I would suggest that this disruptive change offers and opportunity for the MSLs to step up and serve as the face of the company for key studies.

Already many MSL groups get involved in this manner along side CRAs for key studies. In the future MSLs could replace the CRAs for the customer-facing aspects of key studies, just like CDMs will replace CRAs for the electronic source data verification processes. It would require changes to SOPs and some additional work and training for the MSLs but the benefits for the organization would be significant:

MSLs already have relationships with many KOLs which serve as PIs and this is an opportunity to strengthen that relationship as well as build new relationships

MSLs work for the company and therefore understand the importance of building and maintaining long-term positive relationships with the PIs (as opposed to CRAs which are often outsourced and only focused on a single study)

MSLs have superior scientific training than most CRAs and thus can make a stronger case for the scientific importance and structure of the study, which is cited by PIs as one of the key factor’s driving their willingness to engage in the study

MSLs can have peer-to-peer discussions with the PIs to ensure that they understand the protocol

MSLs often glean key scientific insights from PIs when working with them on studies that can be brought back and shared with the organization’s scientific leadership

MSLs can offer their scientific opinion on aspects of the trial that may be limiting recruitment given their in-depth engagement

These are just a few of the benefits for engaging the MSLs in this new manner. But, like all disruptive change, this is not going to come about naturally. For MSLs to engage in this new manner, MA Leadership will need to reach out to their CD counterparts, discuss this disruptive change and push for a new role for MSLs.

1 comment:

Gary-thanks for the insights. There is a great role for MSLs in the clinical trial arena, but as you mention, requires a high-level discussion across MA and CD Operations. My experience is that CD Ops are threatened by the MSLs ability to establish sustainable KOL relationships and try to limit their involvement to recruitment/motivational visits when all else fails. The responsibility sits with MA leadership to provide quantifiable metrics that demonstrate the value of utilizing the MSL earlier in the process. I'm interested to hear if anyone has been successful at this, outside of the oncology space?